Zida Control Sock White Extra Large
Zida Control Sock White Extra Large (8710) is a Class II device made by Exodus Innovation Ltd, cleared under FDA 510(k) K192731 on 19 Mar 2021 and listed in FDA GUDID since 3 Mar 2022 (UDI-DI 07297539087104), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07297539087104 | Date3 Mar 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK192731 | Date19 Mar 2021 | StatusActive |
Official records
- AccessGUDID record 07297539087104
- FDA 510(k) database K192731
Across registries
- FDA 510(k) K192731 decided 19 Mar 2021 Active
- FDA GUDID UDI-DI 07297539087104 listed 3 Mar 2022 Listed
Timeline
- Cleared FDA 510(k) K192731
- Listed FDA GUDID 07297539087104
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Zida
- Generic name
- Sacral plexus implantable incontinence-control electrical stimulation system
- Model / Ref / Catalog
- Control Sock White Extra Large, 8710
- Primary DI / UDI-DI
- 07297539087104
- 510(k) Number
- FDA product code
- NAM
- GMDN term
- Sacral plexus implantable incontinence-control electrical stimulation system
- Device class
- Class II
- Regulation number
- 876.5310
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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- ZIDA Wearable Neuromodulation System by Exodus Innovations
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